Asymchem, a leading global contract development and manufacturing organization (CDMO), announced that its dedicated carbapenem API manufacturing facility (Jilin Asymchem Pharmaceuticals Co. Ltd., also known as 'DH2') successfully completed its first USFDA inspection on June 22, 2026, for a short-notice Pre-Approval Inspection (PAI) which occurred between April 27-30, 2026.
This PAI inspection was conducted in support of a commercial API using continuous raw material feeding and reaction technology, marking a first regulatory milestone for the DH2 carbapenem site commissioned in 2020.
Asymchem's DH2 facility provides custom carbapenem intermediates to APIs supporting clinical into commercial supply. The site houses cutting edge continuous flow ozonolysis capabilities, designed and built in-house by Asymchem's engineering team, with capacity into tonnage scale in support of new chemical entities (NCE). Implementing continuous flow across all Asymchem sites is a priority for heightened operational safety while also reducing the company's carbon footprint.
Dr. Hao Hong, Chairman and CEO of Asymchem Group, said he is proud to continue a successful track record of approvals from regulatory agencies in the U.S., European Union, Japan, China, Australia, Korea, Canada, Brazil and other markets, adding that the first inspection of the Dunhua 2 facility confirms the company's commitment to achieving the highest quality standards.
Across its global operations, Asymchem undergoes around 200 customer audits each year and has completed more than 100 regulatory inspections to date. The company says it remains committed to its Quality by Design (QbD) framework, using science- and risk-based approaches, data-driven decision-making, and integrated control strategies to maintain high-standard quality management throughout the product lifecycle.
